Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Beth Israel Lahey Health

Status: Completed

Conditions: Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Procedure: Tumor collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00801320

07-319

Details and patient eligibility

About

The purpose of this research study is to collect tumor samples at the time of surgery and store them for possible use as part of an experimental vaccine study for the participants cancer in the future.

Full description

• Even if tumor sample is collected, the participant is under no obligation to participate in the vaccine study.
• Participants will have their regularly planned surgery as described by their surgeon. During the surgery, tumor samples will be collected. We will only collect tumor that is not needed and could otherwise be thrown away.
• The tumor samples will be frozen and placed in storage for up to two years.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist
• Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease
• Estimated life expectancy of 6 months or greater
• 18 years of age or older

Exclusion criteria

• More than one prior chemotherapy regimen
• Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
• Known HIV infection
• Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin
• Significant autoimmune disease, including psoriasis
• History of clinically significant venous thromboembolism

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF

Treatment:

Procedure: Tumor collection

Cohort 2

Experimental group

Description:

Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF and topical Imiquimod at site of vaccination

Treatment:

Procedure: Tumor collection